The Flatstent versus the conventional umbrella devices in the percutaneous closure of patent foramen ovale.

Patent foramen ovale (PFO) has been associated with paradoxical embolism leading to stroke/transient ischemic attack, migraine, and neurological decompression sickness. In search for the optimal device that would achieve effective clinical closure with minimal complications, a better device selection based on PFO anatomy and improvements in device design is needed. The Flatstent is a new device designed to treat the highly prevalent long-tunnel PFOs from within, minimizing the amount of material left behind in an attempt to reduce device-related complications. The objective is to compare the safety and efficacy of the novel Flatstent versus the conventional umbrella devices in the transcatheter closure of PFO in a nonrandomized, retrospective, single-center study. Between March 2010 and March 2013, 88 patients underwent PFO closure at The Heart Hospital, London with either the novel Flatstent or one of the four conventionally used umbrella devices (GORE Helex Septal Occluder, Occlutech Figulla Flex, Biostar Septal Occluder, and Amplatzer PFO Occluder) depending on their PFO anatomy. Patients were then evaluated with contrast transthoracic echocardiography (TTE) and/or transoesophageal echocardiography (TOE) at 6 weeks and 1 year after the procedure. The residual shunt and complication rates between the Flatstent and umbrella devices were compared. The Flatstent was used in 27 patients (30.7%), whereas 61 patients (69.3%) received one of the four umbrella devices. Primary efficacy point of clinical closure defined as grade 0 or grade 1; residual shunt was achieved in 81.3% in the Flatstent cohort and 80.3% in the umbrella device group at 6 weeks follow-up. At 1 year, the clinical closure rates reached 92.6 and 91.8%. There were two device embolizations, one in each cohort during the immediate postoperative period (<24 hrs), with successful retrieval. One patient in the umbrella device group developed transient atrial fibrillation, which was controlled medically. Event recurrence rate was 0% at 1 year. No difference was found in closure or complication rates between the Flatstent and the umbrella devices. With appropriate preassessment of the PFO anatomy, the Flatstent works as a safe and effective method of treating the PFO from within the tunnel, especially in those with long-tunnel PFOs. Longer follow-up is needed to establish superiority.

Aral M ，Mullen M 《-》

Transseptal puncture to facilitate device closure of "long-tunnel" patent foramen ovale.

Patent foramen ovale (PFO) is common and may predispose to paradoxical embolism. Transcatheter device closure of PFO can be challenging in certain cases of "long-tunnel" PFO morphology. We report our experience with device closure of long-tunnel PFO using transseptal puncture. We retrospectively reviewed all cases of PFO device closure using transseptal puncture at the Mayo Clinic from January 1, 2010 to September 30, 2013. We arbitrarily defined a PFO tunnel configuration as a tunnel length ≥ 12 mm as observed in intracardiac echocardiography (ICE) at the time of device closure. Twelve patients (mean age 40.8 [range 15-67] years; 7 males [58%]) underwent PFO device closure with transseptal puncture. The most common indication for PFO closure was previous stroke (n = 7, 58%). Median tunnel length measured by ICE was 15 mm (12-20 mm). GORE® HELEX® Septal Occluder was used for closure in all but one patient. The only significant procedural complication was a minor perforation of the left atrial wall during attempted septal puncture, which resulted in a trivial pericardial effusion that resolved without intervention. At latest follow-up (mean 543 days, [range 170-1162]) one patient had a residual shunt and subsequently died due to complications during surgical PFO closure. No recurrent strokes or TIAs were reported. Though not without risk, transseptal puncture can be a valuable tool for facilitating device closure of long-tunnel type PFOs. GORE® HELEX® Septal Occluder may be an effective option for facilitating device closure for patients with long-tunnel type PFO.

Thompson AJ ，Hagler DJ ，Taggart NW 《-》

Initial clinical experience with the Coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure: results of the Coherex-EU study.

The Coherex-EU Study evaluated the safety and efficacy of PFO closure utilizing novel in-tunnel PFO closure devices. Transcatheter closure of patent foramen ovale (PFO) followed the development of transcatheter closure devices designed to patch atrial septal defects (ASDs). The Coherex FlatStent™ and FlatStent™ EF devices were designed specifically to treat PFO anatomy. A total of 95 patients with a clinical indication for PFO closure were enrolled in a prospective, multicenter first in man study at six clinical sites. Thirty-six patients received the first-generation FlatStent study device, and 57 patients received the second-generation FlatStent EF study device, which was modified based on clinical experience during the first 38 cases. Two patients enrolled to receive the first generation did not receive a device. At 6 months post-procedure, 45% (17/38) of the intention-to-treat (ITT) cohort receiving the first-generation FlatStent device had complete closure, 26% (10/38) had a trivial residual shunt, and 29% (11/38) had a moderate to large residual shunt. In the ITT cohort receiving the second-generation FlatStent EF device, 76% (43/57) had complete closure, 12% (7/57) had a trivial shunt, and 12% had a moderate to large shunt. Five major adverse events occurred, all without sequelae. This initial study of the Coherex FlatStent/FlatStent EF PFO Closure System demonstrated the potential for in-tunnel PFO closure. The in-tunnel Coherex FlatStent EF may offer an alternative to septal repair devices for PFO closure in appropriately selected patients; however, further investigation will be necessary to establish the best use of this device.

Sievert H ，Wunderlich N ，Reiffenstein I ，Ruygrok P ，Grube E ，Buellesfeld L ，Meier B ，Schofer J ，Muller D ，Jones RK ，Gillam L ... -  《-》

Transcatheter interatrial septal defect closure in a large cohort: midterm follow-up results.

We evaluated immediate and midterm results of transcatheter closure of atrial septal defects (ASDs) and patent foramen ovale (PFO) using various closure devices. The study included four hundred fourteen patients (one hundred eighty-two men, two hundred thirty-two women; mean age 39 ± 12.3 years; range 17-67 years) who underwent transcatheter closure of secundum ASD (n = 193) or PFO (n = 221). All the patients were evaluated by transthoracic echocardiography and transesophageal echocardiography before the procedure. Transcatheter closure was performed by using Amplatzer (n = 184), Occlutech Figulla (n = 209), or BioSTAR (n = 21) devices. Closure of ASDs was performed under general anesthesia with transesophageal echocardiography guidance, and closure of PFOs was performed under local anesthesia with transthoracic echocardiography guidance. Follow-up controls were at 1, 6, and 12 months and annually thereafter. The median follow-up periods of ASD and PFO patients were 43 and 30 months. The mean device size was 19.3 ± 6.2 mm for ASD patients and 24.6 ± 2.6 mm for PFO patients. The mean procedural and fluoroscopy times were 22.3 ± 4.7 and 4.1 ± 1.9 minutes for ASD closure and 12.4 ± 3.2 and 3.1 ± 1.2 minutes for PFO closure, respectively. Procedural device embolization occurred in only two patients (0.48%). During follow-up, recurrent embolic events occurred in four patients (1.8%) after PFO closure, and no residual shunts were seen after ASD closure. Device thrombosis developed in two ASD patients during the procedure and in one PFO patient at 12th month of the follow-up (0.72%). Transcatheter closure of PFOs and secundum-type ASDs using the Amplatzer, Occlutech Figulla, and BioSTAR devices is an efficacious and safe therapeutic option.

Aytemir K ，Oto A ，Özkutlu S ，Canpolat U ，Kaya EB ，Yorgun H ，Şahiner L ，Sunman H ，Ateş AH ，Kabakçı G ... -  《-》

Mid-term results of interventional closure of patent foramen ovale with the Occlutech Figulla(®) Flex II Occluder.

Neuser J ，Akin M ，Bavendiek U ，Kempf T ，Bauersachs J ，Widder JD ... -  《BMC Cardiovascular Disorders》